Project Manager - R & D Project Management - Pharma
- Kusum
- 10 - 15 years
- Delhi, NCR
- 22 days ago
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Job Description
Role & responsibilities
- Develop detailed tech transfer project plans with milestones, timelines, budgets and resource allocation.
- Lead transfer of products from R&D to commercial scale or site-to-site transfers.
- End-to-End Launch Project Management
- Cross Functional Coordination/ Stakeholder Management
- Risk Management- Identify project risks and bottlenecks and Create mitigation plans
- Commercial Launch Readiness- Support first commercial batch release and dispatch, coordinate artwork, pack material availability, RM/PM readiness
- Ensure readiness of TT dossier, BMR/BPR, specifications, SOPs, validation protocols.
- Manage change controls, deviations, CAPA, risk assessments.
- Ensure compliance with cGMP, WHO-GMP, EU GMP, US FDA, MHRA, CDSCO requirements.
- Track approvals from Central Drugs Standard Control Organization and export agencies.
- Ensure license variations / artwork approvals / submissions completed.
- Process mapping and gap assessment.
- Equipment fitment review.
- Trial batches / exhibit batches / engineering batches.
- Process validation / PPQ batches.
- Analytical method transfer.
- Stability study initiation.
Skills Required
- Strong project management skills
- GMP / regulatory understanding
- Tech transfer lifecycle knowledge
- MS Project / Excel / ERP / SAP knowledge
Preferred candidate profile
- B.Pharm / M.Pharm / M.Sc /MBA with 10-15 years pharma manufacturing/project management experience, PMP preferred
- Plan and execute tech transfer projects, lead product/site transfers, manage launch readiness, ensure documentation and regulatory compliance, coordinate cross-functional teams
- Experience in oral solids, injectables, hormones, oncology, sterile or regulated market products preferred.
- Exposure to CDMO / site transfer / global launches desirable.
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Project & Program ManagementRole Category: Other Program / Project ManagementRole: Project ManagerEmployement Type: Full timeContact Details:
Company: KusumLocation(s): Delhi, NCR+ View Contact
Keyskills: R & D Project Managment New Product Launch Tech Transfer Project Management
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₹ 18-25 Lacs P.A
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Kusum
Founded in 1997, Kusum Healthcare Pvt Ltd. is a 100 per cent export-oriented pharmaceutical company, headquartered in New Delhi, India. A fully integrated, young pharmaceutical company having three state-of-the-art manufacturing units in India: two in Bhiwadi Rajasthan, and another one in Indore, Ma...
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